| CTRI Number |
CTRI/2023/05/052562 [Registered on: 12/05/2023] Trial Registered Prospectively |
| Last Modified On: |
09/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Trial of Yamani Churn in warm infestion in children . |
|
Scientific Title of Study
|
Randomized open controlled clinical trial to evaluate the efficacy of Yamani Churna in PURISHAJA krimi w.s.r. to ascaris lumbricoides in children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati Sheshraoji Umak |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic Hospital Kodoli ,Kolhapur |
| Address |
OPD No 7 Kaumarbhritya OPD Yashwant Ayurved Hospital Kodoli Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7066288864 |
| Fax |
|
| Email |
swatiumak07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh R Rajgolkar |
| Designation |
Associate Professor |
| Affiliation |
Yashwant Ayurvedic Hospital Kodoli Kolhapur |
| Address |
OPD No 7 Kaumarbhritya OPD Yashwant Ayurved Hospital Kodoli Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8308410222 |
| Fax |
|
| Email |
shaileshrajgolkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Sheshraoji Umak |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic Hospital Kodoli ,Kolhapur |
| Address |
OPD No 7 Kaumarbhritya OPD Yashwant Ayurved Hospital Kodoli Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7066288864 |
| Fax |
|
| Email |
swatiumak07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic college Near Sub District Hospital kodoli Tal Panhala District Kolhapur Pin Code 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Swati Sheshraoji Umak |
| Address |
OPD No 7 Kaumarbhritya OPD Yashwant Ayurved Hospital Kodoli Kolhapur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swati Umak |
Yashwant Ayurved Hospital Kodoli |
OPD No 7 Yashwant Ayurved Hospital Kodoli Kolhapur
Kolhapur
MAHARASHTRA |
7066288864
swatiumak07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B770||Ascariasis with intestinal complications. Ayurveda Condition: PURISHAJAKRUMIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yamani Churna, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Albendazole | Albendazole
Tablet or Suspension
400 mg Single Dose |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients irrespective of gender having sign &
symptoms of purishaja krimi within age group
of 2-12 years
Patients who shows eggs of Ascaris
Lumbricoides in microscopic stool
examination
Patients giving past history of having round
worms in their stool
Only those patients will be selected whose
parents are willing to give written consent. |
|
| ExclusionCriteria |
| Details |
Patients associated with K/H/O or any acute
or chronic systemic disease like pneumonia,
tuberculosis,severe anemia, and Chronic
Heart Disease.
Subjects who already have received
deworming medicine within last 6 months
Patients not willing for trial |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To decrease the symptoms of PURISHAJA KRUMI wsr to ascaris lumbricoides on assessment of subjective and objective criteria like stool examination and complete blood count |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study etiopathology of PURISHAJA krimi and ascaris lumbricoids in detail
To achieve outcome in 30 days |
30 days |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomized open controlled clinical trial to evaluate the efficacy of Yamani Churna in PURISHAJA krimi w.s.r. to ascaris lumbricoides in children. Observation will be made upon symptoms of PURISHAJA krimi w.s.r. to ascaris lumbricoides.Study will be carried in OPD Kaumarbhritya of Yashwant Ayurvedic College Kodoli Kolhapur |